What Should Medical Device Makers Pay Attention to Under New EU Rules?

The European Medical Device Regulation (MDR) requires manufacturers to closely monitor their products after they reach the EU market.

Avoiding Common CAPA Mistakes in Medical Device Quality Management

The CAPA (Corrective and Preventive Action) process for medical devices is at times threatened by common mistakes, but there are strategies to avoid them.

Clinical Quality Management Systems (CQMS) in the Life Sciences Industry Dissected

A blog post by Quality Systems Now shows that a Clinical Quality Management System (CQMS) plays a crucial role in ensuring the safety and success of clinical trials.

Licensing or Accreditation: The Crucial Choice for New Ventures in Pharma and Medical Devices

When launching Greenfield projects in the pharmaceutical or medical device industries, businesses often face the decision between Good Manufacturing Practice (GMP) licensing and ISO 13485 accreditation.

Process Development and Identification of Critical Process Parameters in Medical and Pharmaceutical Industries

Identifying and controlling Critical Process Parameters (CPPs) is essential to maintaining quality and consistency in medical and pharmaceutical industries, according to Quality Systems Now's blog post.

Classification of Medical Devices under EU MDR

Dr. Murugan Kandasamy, Managing Director & CEO at DQS India, Head - Medical Global Support Center, has published a new blog post about Classification of Medical Devices under EU MDR. The most important issues he discusses are:

Certification NEN 7510:2024: against which part?

Pim Lagrand, Information security advisor, discusses the new version of NEN 7510:2024, Dutch standard for Information Security in healthcare.

Efficient Supplier Management for Medical Devices Manufacturers

Andy Chiou from DQS discusses the importance of efficient supplier management for medical device manufacturers under ISO 13485 compliance.